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Statistical Considerations
• Enrollment of 1050 patients was planned; 1069 patients were randomized
• This final PFS analysis and interim OS analysis were based on a 28 August 2020 data
cutoff date (median follow-up: 27 months), at ~388 PFS events for 90% power with
2-sided α = 0.045
• The observed number of final PFS events:
• 365 for LEN + PEMBRO versus SUN
• 396 for LEN + EVE versus SUN
• PFS and OS differences between LEN + PEMBRO versus SUN, and LEN + EVE versus SUN,
were evaluated using a stratified log-rank test